Biologics

Questions Raised About Biologics Interchangeability

Georgia State University law professor Yaniv Heled says a new FDA guidance explaining how drug manufacturers can develop follow-on biologics is a good step toward lowering drug costs, but may not be enough to make a real difference. Writing online for The Conversation, Heled explains why biologics are so expensive (often costing many tens to hundreds of thousands of dollars a year) and what the FDA guidance hopes to accomplish to lower costs.

He says the 2010 Biologics Price Competition and Innovation Act only created a legal pathway for follow-on biologics and didn’t address the technical challenge of comparing an original, expensive biologic with its cheaper imitation, leaving that to FDA to figure out.

Heled says the new guidance provides instructions for proving that two products, an original biologic and the follow-on, are similar enough to be deemed substitutable. “Once FDA approves interchangeable versions of biologics, this should drive competition in biologics and, ultimately, cause their prices to drop,” he writes…. “But concerns remain that FDA’s guidance might not be enough to drive down prices significantly. Development of similar biologics is estimated to cost about $100 million to $200 million. This is much higher than the development of generic drugs, which is estimated to cost, typically, between $1 million and $5 million. There are not very many companies with the kind of facilities, expertise, and money necessary to develop interchangeable versions of biologics and chaperon them through FDA’s approval process. As a result, it is quite possible that there will not be a lot of companies able to compete.”

He also notes that the guidance applies only to protein products and there is still no clear regulatory path for FDA to approve interchangeable versions of some of the most expensive biologics, such as gene therapies.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome